TY - JOUR T1 - Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 199 LP - 212 DO - 10.5731/pdajpst.2017.007955 VL - 72 IS - 2 AU - David Jones AU - Tony Cundell Y1 - 2018/03/01 UR - http://journal.pda.org/content/72/2/199.abstract N2 - The Growth Directâ„¢ System that automates the incubation and reading of membrane filtration microbial counts on soybean-casein digest, Sabouraud dextrose, and R2A agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation.LAY ABSTRACT: The Growth Directâ„¢ System that automates the incubation and reading of microbial counts on membranes on solid agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation time. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation. ER -